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使用鼻咽拭子检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染的四种快速抗原检测方法的评估

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs.

作者信息

Lim Ho-Jae, Park Min-Young, Baek Young-Hyun, Lee Hyeon-Seo, Kim Inhee, Kwon Youngjin, You Youngshin, Nam Kyoungwoo, Yang Jae-Hyun, Kim Min-Jin, Yu Nae, Sohn Yong-Hak, Park Jung-Eun, Yang Yong-Jin

机构信息

Department of Molecular Diagnostics, Seegene Medical Foundation, Seoul 04805, Republic of Korea.

Department of Integrative Biological Sciences & BK21 FOUR Educational Research Group for Age-Associated Disorder Control Technology, Chosun University, Gwangju 61452, Republic of Korea.

出版信息

Biomedicines. 2023 Feb 24;11(3):701. doi: 10.3390/biomedicines11030701.

Abstract

Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription-polymerase chain reaction (rRT-PCR) is limited. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required. Here, using 1503 nasopharyngeal swabs, we compared the diagnostic performance of four RAT kits (Abbott Panbio™ COVID-19 Ag Rapid Test, SD Biosensor Standard™ Q COVID-19 Ag Test, Humasis COVID-19 Ag Test, and SG Medical Acrosis COVID-19 Ag Test) to the cycle threshold (Ct) values obtained from rRT-PCR. The precision values, area under the curve values, SARS-CoV-2 variant detection ability, and non-SARS-CoV-2 specificity of all four kits were similar. An assay using the Acrosis kit had a significantly better positive detection rate with a higher recall value and cut-off value than that using the other three RAT kits. During the current COVID-19 pandemic, the Acrosis kit is an effective tool to prevent the spread of SARS-CoV-2 in communities.

摘要

由于严重急性呼吸综合征冠状病毒2(SARS-CoV-2)变体的高传播性,基于金标准实时逆转录聚合酶链反应(rRT-PCR)的检测系统能力有限。快速抗原检测(RATs)可对预防社区传播做出重大贡献,但需要对其进行进一步评估。在此,我们使用1503份鼻咽拭子,将四种RAT试剂盒(雅培Panbio™ COVID-19抗原快速检测试剂盒、SD生物传感器标准™ Q COVID-19抗原检测试剂盒、Humasis COVID-19抗原检测试剂盒和SG Medical Acrosis COVID-19抗原检测试剂盒)的诊断性能与从rRT-PCR获得的循环阈值(Ct)值进行了比较。所有四种试剂盒的精密度值、曲线下面积值、SARS-CoV-2变体检测能力和非SARS-CoV-2特异性均相似。使用Acrosis试剂盒的检测方法比使用其他三种RAT试剂盒的检测方法具有显著更好的阳性检出率,召回值和临界值更高。在当前的COVID-19大流行期间,Acrosis试剂盒是预防SARS-CoV-2在社区传播的有效工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5f2/10045780/1036e0d7dcd0/biomedicines-11-00701-g001.jpg

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